Category: opinion

Change of the Guard

What might the new U.S. President’s administration have in store for the vapor industry?
By Patricia Kovacevic
At the time of writing, the results of the U.S. elections are still contested by the presidential incumbent, a Republican, via various vote recount requests and litigation; however, it is a virtual certainty that the U.S. will have a new president, representing the Democratic Party, as of Jan. 20, 2021.
The heads of departments, including the head of the Department of Health and Human Services (HHS), are appointed by the president, subject to confirmation by the Senate, and typically change with the administration. In turn, the Food and Drug Administration (FDA), which is the agency within the HHS with primary jurisdiction over tobacco products (including electronic nicotine-delivery systems, or ENDS) as well as drugs, foods and other products, will be led in the new administration by a new commissioner.
Given the Covid-19 crisis, the new president will be under immense pressure to appoint a new FDA commissioner immediately. Interestingly and somewhat surprisingly, a former FDA commissioner, David Kessler, was recently named co-chair of the new administration’s Covid-19 task force, although Kessler resigned his commissioner role in November 1996 amid controversy for overbilling his travel expenses during his tenure.
Also during Kessler’s tenure, the FDA attempted to regulate tobacco products as “delivery devices for the drug nicotine” to bring tobacco products under FDA jurisdiction. Tobacco companies challenged the rules all the way to the Supreme Court and won (FDA v. Brown and Williamson Tobacco Corp.). The Supreme Court ruled that “Congress has clearly precluded the FDA from asserting jurisdiction to regulate tobacco products. Such authority is inconsistent with the intent that Congress has expressed in the FDCA’s [Food, Drug and Cosmetic Act] overall regulatory scheme and in the tobacco-specific legislation that it has enacted subsequent to the FDCA. In light of this clear intent, the FDA’s assertion of jurisdiction is impermissible.”
Kessler’s wish to see tobacco regulated by the FDA was eventually granted by Congress in June 2009 through the bipartisan passage of the Family Smoking Prevention and Tobacco Control Act. While some speculate that Kessler may be on the short list for HHS commissioner, it is likely that the administration will bring forward new faces. Still, Kessler’s life-long anti-tobacco stance and past working relationship with the current head of the Center for Tobacco Products might give an indication of the increased scrutiny of the tobacco sector in the years to come.
Patricia Kovacevic
The ENDS industry status quo, from a legislation point of view, while far from ideal, is by now familiar to the ENDS industry. The recent premarket tobacco product application (PMTA) filing deadline has come and gone, and, as expected, we have not seen a flurry of warning letters post-September 2020 ordering certain vapor manufacturers to stop selling their products because they did not submit a PMTA.
The FDA is, however, expected to start enforcing this legislation sooner or later. For any dramatic change to occur, the governing legislation, the Food, Drug and Cosmetic Act, would have to be amended, which is not likely to be top of the list for the upcoming Congress given the priorities the new administration announced during the election campaign. Still, the House of Representatives, one of the chambers of the U.S. legislature, remains dominated by the Democrats, the same party whose representatives initiated several tobacco-related bills and called for confrontational hearings on vapor products. The most recent one, in February 2020, was relatively tame compared with the tone of the July 2019 Juul hearing and even with the June 2014 Senate hearing.
Senate races in Georgia will require runoff elections on Jan. 5, 2021. If Democrats gain both Senate seats in Georgia in January, there would be a 50-50 tie in the Senate, and the vice president would have the tie-breaking vote in case the Senate is deadlocked on a piece of legislation. When the House, Senate and White House are controlled by the same party, the chances of the current administration to pass laws in support of its agenda are greatly increased, though divisions exist within each party, and surprises always happen. Furthermore, 34 out of the 100 Senate seats are up for regular election in two years as well as all 435 House seats; these will be a trying two years for Americans in an economic crisis, and the public sentiment can swing in the other direction. Thus, the new president may have only two years, if even that long, to pass a flurry of laws, and there may be more urgent matters than revisiting the Tobacco Control Act, which, for better or for worse, has worked so far.
The FDA already has broad powers to expand requirements and restrictions involving ENDS products, including the authority to impose product standards through notice-and-comment rulemaking. Ingredient caps and bans are among the standards the FDA has the authority to promulgate via regulation.
The latest unified agenda of regulatory and deregulatory actions
As of spring 2020, active regulatory actions include four potential future regulatory actions by the FDA, rolled over from previous agendas, with no clear deadline for publication of a proposed rule:
Requirements for Tobacco Product Manufacturing Practice (colloquially referred to as “Good Manufacturing Practices”)
Tobacco Product Standard for Characterizing Flavors in Cigars (follow-up to the 2018 Advance Notice of Proposed Rulemaking); this is unlikely to move into the final rule stage on account of recent courtroom successes by the cigar industry.
Modified-risk tobacco product applications; this future proposed rule would establish content and format requirements to ensure that modified-risk tobacco product applications contain sufficient information for the FDA to determine whether it should permit the marketing of a modified-risk tobacco product. Additionally, the proposed rule would set forth the basic procedures for modified-risk tobacco product application review and require applicants receiving authorization to market a modified-risk tobacco product to establish and maintain records, conduct post-market surveillance and studies, and submit annual reports to the FDA.
Premarket tobacco product applications and recordkeeping requirements, a 2019 proposed rule, which would have as a next step at some point in the future, likely in 2020, a final rule.
Notably, ingredient bans and nicotine caps are not on the regulatory agenda. A first step toward an ingredient ban would likely be an Advance Notice of Proposed Rulemaking (ANPRM), although the FDA can in theory skip this step and move directly to a proposed rule, open a docket for comment, collect comments and consider whether it has sufficient information to finalize the rule. Given the complexity of the issue and the current research focusing on flavor ingredients in ENDS, if the FDA determines that an exploration of a flavor ban is desirable, the FDA will probably go through the ANPRM step.
One would have to wonder, though, why engage in rulemaking when the FDA already reviews all relevant information about every ENDS product on the U.S. market, present and future, through the PMTA process—thus allowing the agency to make a case-by-case determination—and the FDA will no doubt pay considerable attention to certain flavored products. In the author’s personal opinion, the PMTA process is the FDA’s preferred avenue to make decisions on individual products rather than issuing rules on product categories, which can also be challenged—and the current Supreme Court might entertain challenges to the FDA’s behavior if it came to it down the road.
Meanwhile, the majority of states by number still lean conservative, which likely means fewer developments in taxation, some scrutiny of ENDS but not necessary priority placed on shrinking the lawful ENDS market as there is no immediately quantifiable health benefit from doing so, and many potential harms. Of note are the California litigation and the potential referendum in California to overturn SB 793 (the flavor ban legislation). By the time this you read this article, we should know whether the bill opponents succeeded at collecting the necessary signatures to place the referendum on the November 2022 California elections ballot and suspend the application of the California flavor ban until then and pending the referendum’s outcome.
The question we must also ask, given the political, public health and economic crisis context is whether ENDS are a threat to anyone and why any administration would, at this juncture, prioritize overregulating a harm reduction asset over the important, systemic changes Americans expect from the administration and drastically mitigating the Covid impact. The industry is likely to consolidate and survive.
A global legal and compliance nicotine industry expert, Patricia I. Kovacevic has experience that includes general counsel and chief compliance officer roles at Nicopure Labs as well as leading senior legal and regulatory positions at Philip Morris International and Lorillard. Kovacevic served on the board of directors of the Vapor Technology Association and on the advisory board of the Global Tobacco & Nicotine Forum. She is the founder of RegulationStrategy, a global legal and compliance FDA-regulated industry consultancy.
December 23, 2020
CTFK Funding Under Fire in Colorado City’s Flavor Fight
By Timothy S. Donahue
The truth is trickling out on Campaign for Tobacco -Free Kids (CTFK). In the documentary You Don’t Know Nicotine,one source exclaims that CTFK is a “dark money organization” that is “just about as greedy as Big Tobacco.” The organization is accused of using its massive amounts of funding to shutter small businesses by using false rhetoric and bad science about e-cigarettes and other vapor products. This has helped create a “regulatory environment where only the wealthiest people will be able to play.”
Credit: Ryan McGuire
During a Dec. 8 city council meeting in Loveland, Colorado, that centered on banning flavored e-cigarettes, the accusations levied against CTFK in the film played out in reality. Jodi Radke, the regional advocacy director for CTFK for the Rocky Mountain/Great Plains area, was accused of making false and misleading statements about several Loveland council members in a local newspaper ad and in several social media posts.
She accused the council members of being in cahoots with major tobacco companies. Those members took great offense to the accusations. Radke admitted to not having attended the meeting her social media posts referenced and had received her information anecdotally. She also said she did not validate what was being told to her with any of the council members she accused.
“How do you assume I’m pro-tobacco?” council member Don Overcash asked. Overcash said he did not smoke cigarettes, vape or have any tobacco industry affiliations. When asked how she garnered the information for her organization’s ad and social media posts since she did not attend the referenced meeting, Radke replied, “I don’t feel it is a question that should be directed towards me.” Radke would not directly answer other questions from named council members concerning the ad or posts. She said all CTFK actions and policy “are based on science and evidence.”
Several council members also questioned CTFK’s funding and its sources. Radke said she did not know anything about CTFK funding other than that it came from several major donors, including billionaire anti-tobacco activist Michael Bloomberg. Greg Conley, president of the American Vaping Association, told council members that CTFK had $109 million in its coffers as of 2020 and received an additional $50 million to $60 million per year from Bloomberg (on top of the billionaire’s regular CTFK funding) to help enact flavor bans at the local level. “[At CTFK], science is constantly ignored,” Conley said. “Studies show that flavor bans actually increase the use of [combustible] cigarettes.”
Radke was also asked by council member John Fogle if the CTFK had ever considered using some of its “hundreds of millions” in funding to help the small businesses affected by CTFK’s agenda. After saying she couldn’t answer the question several times, Radke finally replied that she couldn’t answer the question because CTFK had data that showed “small businesses don’t lose money” because of CTFK policies.
After several hours of debate, the potential vote was postponed to a meeting in February. For vapor advocates, it was just another day fighting well-funded misinformation campaigns around the globe.
December 21, 2020
Overcash: In Flavor Ban, Loveland Council Losing Focus
How did the Loveland City Council go from discussing teen vaping to a ban on dozens of products legal for adult purchase? To get to the root of this controversy, I’ll refer to two positions regarding choice and responsibility.
The first position: As an adult, I can think for myself and make informed decisions. My body, my choice.
The second position: Adults are not capable of making good choices. We need to protect people from themselves.
We acknowledge alcohol and tobacco abuse lead to health issues. Yet society has decided to handle these products through health education and access restrictions, while respecting adults’ personal choices. Bans create black markets, and history has demonstrated suppliers will always find ways to provide what consumers want. Decreasing demands works better than decreasing supply.
Don Overcash / Credit: Loveland, Colorado
On Dec. 4, the House of Representatives voted for national marijuana legalization. The law doesn’t claim marijuana is free from health concerns, but that informed adults should be free to make a personal choice. Local governments will create access restrictions to protect kids, as they do with alcohol and tobacco.
Campaigns to ban or promote certain products often have catchy names and slick marketing strategies, and they are nationally organized and locally deployed for maximum effect. And there is nothing wrong with executing a well-developed plan.
However, the truth is often lost in the battle for public favor. The proven way to win is to use emotion, along with facts and logic selectively chosen to justify a position. Obfuscation is common. Campaign workers get paid to win. This is the nature of competition in the marketplace of ideas, each side using their power to shout their position. Citizens must sort out what is true and false.
Former New York City Mayor Michael Bloomberg and others have championed many “protect people from themselves” initiatives, including regulations on salt, firearms, vaping, tobacco, and even soft drink serving sizes. Bloomberg also supports the nonprofit “Tobacco-Free Kids.” Perhaps a margarita ban is on the horizon, given the drink’s combination of alcohol, sugar, and salt.
Most of these issues are handled by national or state bodies, such as the FDA, to avoid the unintended consequences and confusion that might result from a patchwork of local bans. Non-federal government bodies do have a role to play, however, in the distribution and sale of select products such as alcohol, tobacco, and — if nationally legalized — marijuana.
When the vaping topic first came before the Loveland City Council, the focus was on limiting access for kids without impeding adults’ freedoms, similar to restrictions on alcohol and tobacco.
I believe council members became wrapped up in anti-tobacco emotion without considering the very real impact a flavored tobacco ban will have locally. While the intent of the ban is to protect our kids, the task force and council have not considered its harsh impact on over 60 Loveland small businesses, their hundreds of employees, and our adult citizens’ freedom of choice. Any serious consideration would reveal these impacts, and council has fortunately delayed further discussion pending a more thorough investigation.
It is apparent this vaping debate has more to do with ideology than Loveland’s kids, given the recent false advertisements accusing three council members by name of being “for Big Tobacco” at the expense of our children. These advertisements were developed and paid for by Tobacco-Free Kids.
Yet every member of the council has clearly supported access restrictions for minors for tobacco, alcohol, and vaping products. The real challenge is how we can do so without impeding Loveland businesses, and without frustrating thousands of Loveland citizens who legally purchase these products. An outright ban is an issue for the FDA.
Councilor Wright bought us some time to consider all factors with a delay until February 2021. I believe an amendment to the proposed ordinance would be in the best interest of Loveland citizens. This amendment would include:
• License requirements for retail outlets.
• A minimum purchasing age of 21.
• An active enforcement policy, including penalties for violation.
• No restrictions on existing flavored tobacco products.
• Limiting sales to age-restricted stores and age-restricted partitions of large stores.
I believe in adults’ freedom of choice and protecting our kids.
Don Overcash is Loveland’s mayor pro-tem. He represents Ward IV on the City Council.
December 15, 2020
Graham: Vaping Bans a Smokescreen for Elitist Agenda

Credit: Pexels Dede Avez
San Francisco’s proposed ban on vaping — inside your own apartment — is so anti-science, so counter to public health and so God awful stupid that I’m stunned Massachusetts didn’t do it first.
If you haven’t heard, the San Francisco Board of Supervisors voted 10-1 to ban smoking and vaping in apartments inside buildings with three or more units — unless you’re smoking or vaping pot, in which case it’s way cool and totally awesome, writes Michael Graham, whose editorial first appeared in the Boston Herald.
The alleged purpose of the ban is to protect your neighbors from the smoke you’re exhaling in your home. But as Dr. Michael Siegel of Boston University noted during a media conference call hosted by InsideSources Thursday, that claim fails two key points: If you’re banning “smoke,” how can you let people smoke pot? And why would you ban vaping, which doesn’t emit any smoke at all?
Michael Siegel
“San Francisco has taken an action which is not evidence-based,” Siegel said. “If I’m holding an electronic cigarette, there’s literally nothing coming out of that electronic cigarette,” Siegel said, “There is no ‘secondhand vapor.’”
Siegel is a nationally renowned anti-smoking advocate and expert on public health. He’s no fan of cigarettes, which is why he opposes bans on safer alternatives like vaping.
Combustible cigarettes are far more dangerous than their e-cig and vaping counterparts, the risk-comparison equivalent of a grizzly bear vs. a Gummi Bear.
But lifestyle-policing liberals in San Francisco and Boston don’t care. That’s why Gov. Baker and the Beacon Hill boneheads banned flavored vaping in 2019. The result? Lines at New Hampshire vape shops and more people turning to flavored cigarettes.
No problem — Massachusetts banned those, too, as of June 1, 2020. And what happened?
Massachusetts saw a 17% drop in cigarette sales year to year, says Ulrik Boesen of the Tax Foundation, who joined Dr. Siegel on the conference call. Good news, right?
“But in Rhode Island and New Hampshire their sales increased by 56%, Vermont’s by 21% and Maine by 30%. Significant increases in all the neighboring states simply because Massachusetts banned a popular product,” Boesen said.
“That means they did not achieve their public health goals, which was to get fewer people to smoke.”
Boesen’s the expert, but I have to disagree. The good-hearted, electric-car driving, NPR-listening liberals did achieve their goal. It just had nothing to do with public health.
No, their real goal is to make sure you smokers know they think you’re a bunch of losers.
Banning menthol smokes or vaping in your private apartment isn’t public health policy, it’s a punishment of the peons by the cultural elite.
“If the principle here is that nobody in an apartment should be exposed to harmful combusted products from an adjacent apartment, then there’s no justification for saying, ‘We’re banning tobacco, but not cannabis,’” Siegel said. And if there were, in fact, any principles at play, he’d be right. But this is pure classism, Commonwealth-style.
Which is why Massachusetts has made it easier to vape dangerous THC products than mango-flavored water vapor, and why San Francisco’s ban on “smoking” exempts the fog of marijuana fumes wafting from your bong.
Ban pot? No way, progressives answer. We smoke pot!
Dr. Siegel’s take on banning vaping in your home? “I think we should be doing the opposite. We should be encouraging smokers to switch to vaping, and we should encourage them to be vaping in their apartments rather than smoking, because the effects of secondhand smoke are substantial — especially if they’re living with children.”
He’s right, of course. But why “encourage” low-income, working class folks when “judging” them is so much more fun?
Any opinions expressed in the above article are solely the author’s and may not be the opinion of Vapor Voice or its parent, TMA.
December 4, 2020
Mushava: Zimbabwe Should Seek Smoke-Free Future
Simbarashe Mutsine started smoking uncured tobacco at the age of 16. Now aged 43, Mutsine is bed ridden and battling for his life. He has been in and out of hospital suffering from a cocktail of health complications that doctors blame on his smoking habits, writes Everson Mushava in Zimbabwe’s The Standard.
Photo: Vchalup | Dreamstime.com
The Chinhoyi tobacco farmer has been experiencing respiratory complications and his blood pressure has also been high for some time. Doctors fear the worst saying arteries that carry blood to his heart muscle have been narrowed by clots caused by chemicals contained in cigarette smoke.
Mutsine has symptoms of coronary artery disease and can suffer a severe heart attack anytime, the doctors said. As if that was not enough, the father of five has also developed type two diabetes mellitus.
“We have lost hope, we have tried all we can but I think he is losing the war,” Mutsine’s sister, Chenayi said, looking dejected. “We thought he was bewitched, but the doctors blame his sickness on smoking. He has since stopped smoking because of ill-health, but there has been no change. We are placing everything in God’s hands.”
Mutsine is not alone in his troubles. According to the World Health Organization, tobacco smoking accounts for over seven million deaths worldwide, of which about five million will be men. Of the 7.1 million deaths recorded in 2016, 6.3 million were attributable to cigarette smoking while the other 884 000 were as a result of second-hand smoke.
The only hope is in a smoke-free future.
The carnage can be stopped.
American tobacco giant, Philip Morris International (PMI), through science and research, has already made a breakthrough that can save million lives and also bring relief to many countries, Zimbabwe included, whose economies are partly sustained by the golden leaf.
PMI has already produced a heating tobacco system; IQOS, which is unique in that it heats tobacco, but does not burn it. The electronic IQOS device generates a nicotine-containing aerosol by heating tobacco-filled sticks wrapped in paper.
Heating of the tobacco in controlled temperatures will significantly reduce the production of harmful chemicals produced through combustion. This was acknowledged by the US Food and Drug Administration (FDA), who in July gave Phillip Morris the greenlight to market its IQOS in the USA.
Since 2016, international tobacco giant has been committing itself to science and research to transform its business towards healthier, smoke-free alternatives to nicotine delivery. The company aims to get at least 40 million of its adult customers to stop cigarette smoking and switch to one of the alternatives aimed at ultimately achieving a “smoke-free future.”
“A lot of people think it’s the nicotine in cigarettes that causes morbidity and mortality. But it’s not. Nicotine is addictive, but it’s not the primary cause of disease,” Andre Calantzopoulos, PMI chief executive officer told the Harvard Business Review in July. “The Food and Drug Authority (FDA) has clarified that. The problem is combustion. If you can eliminate combustion, then you significantly reduce the harmful chemicals the product emits compared to cigarette smoke. The best thing a smoker can do, of course, is to stop nicotine consumption altogether. But a billion people still smoke, so the next best thing you can do is to convince them to change their behaviour by creating products that they can switch to. That is what we are doing.”
He added: “Well, if you do a phase-out too early, you create unintended consequences, including contraband and so on. But with the right demand and supply measures, I think we can eliminate cigarettes in certain countries within reasonable time horizons – 10, 15 years.”
Asked if he had confidence that the transformation would be successful, Calantzopoulos said: “Why would I engage my company in a multibillion-dollar transformational exercise if I didn’t believe that it was the right thing to do?”
According to WHO, although tobacco products pose major public health problems, tobacco products remain one of the consumer products that are virtually unregulated in respect of contents and emissions.
Due to the challenges associated with the regulation of tobacco products, countries have been hesitant to implement regulations in the area because of the highly technical nature of policy interventions involved.
The tobacco industry also poses a challenge in translating science into regulation.
Experts believe failure to regulate tobacco products has presented a missed opportunity towards achieving a smoke-free future.
However, reduced risk tobacco products are still regulated in the same way as traditional cigarettes in order to prevent people especially in low-to-medium-income countries from accessing products that could reduce the harm that cigarettes pose to their lives.
November 30, 2020
Vape maker SnowPlus Says Truth Must be Told About EVALI
Maybe no one specifically asked for it, but when the first e-cigarette hit the shelves of bodegas and corner stores in 2010, this innovative nicotine delivery tool started making waves in smoker groups in urban centres in the US and Asia. For the better part of the following decade, smokers began to open up to this new tech as a possible replacement or pathway to quitting smoking and continued to convert smokers across the globe.
Credit: Elsa Olofsson
That all abruptly changed in August of 2019, when an Illinois man succumbed in hospital to a mysterious lung disease caused by a vaping product — 2,807 more Americans are hospitalized for vape related illnesses following. At the same time, certain industry players drew public ire for using unscrupulous marketing tactics seen as targeting underage users.
Yet instead of covering these two parallel stories in a way that’s in the best interest of public health, it quickly turned into a media firestorm combining both instances into one, spurring a race for headlines often spreading misinformation. Even President Donald Trump rode the media wave saying he would take ‘very, very strong action’ in September of 2019, then backpedaled a few months later.
In the height of the media frenzy, the CDC swiftly mobilized and better understood the lung illness, later named ‘e-cigarette, or vaping product use lung injury’ or EVALI for short. The findings found that vitamin-E acetate, a thickener in THC vape products (which are illegal for sale in the US, by the way) was the culprit. The research led to the potential source of these products, weeding them out to ensure less people get exposed to these black-market products.
Yet the general public was only hearing a generalized perspective of: “vape is bad.”
While governments reactively regulated, credible vape companies already aligned to FDA and EU specifications continued to offer the millions of smokers around the world an alternative to smoking tobacco. Still, the media narrative abandoned the smoker looking for an alternative and focused only on the convoluted story of ‘vape is bad!’
This position though, was not shared globally. The UK and EU experienced steady adoption in the vape category, with more and more smokers transitioning over to what UK Public Health says is 95% safer than smoking. In countries like Germany with more fully-fledged regulatory policies, youth vaping hasn’t appeared to be a problem.
Experts have pointed out that EVALI cases are almost exclusive to the United States and haven’t made a blip on the radar globally. In the UK, there are approx. 3.6 million e-cigarette users with virtually no EVALI cases reported during the media coverage period in 2019.
The EU experience was somewhat similar to what we saw here at home during that period. “EVALI was largely the result of an unregulated illicit THC vape market in the United States which didn’t follow safe production standards” says Allan Rewak, Executive Director of VITA. “Canada’s nicotine vape market was on the final path toward federal regulation at the time, which prevented EVALI from occurring in any significant way north of the border.”
Brad Jemmett, a former long-time smoker and now General Manager for SnowPlus – an innovation based vape company – suggests that the core of what drove the negative media was a localized, US issue. “Globally, we don’t really see EVALI cases like there were in the US, because EVALI was linked to illicit marijuana vapes, and most specifically the addition of Vitamin E acetate as a thickening agent. Our products on the other hand, are developed and tested to the highest degree, and designed specifically for adult smokers looking to transition out of smoking. At SnowPlus, we never have and never will use Vitamin E acetate in any of our products. Through innovation, we’ve aimed to simulate the smoking ritual with vape technology, to provide a less harmful alternative compared to smoking cigarettes”.
Brad, like many of the former smokers out there that have successfully transitioned from smoking to vaping, hope that those who are looking for an alternative to smoking can see a clearer picture now that the dust has settled, and the fake click-bait news headlines about vaping have passed. It may be time for smokers who want to butt out of the habit to reopen the conversation about alternatives that have a track record of working.
November 30, 2020
Gcoyi: South Africa Needs Fair Vapor Regulations
The hype of the past few years around nicotine delivery systems such as vapes and e-cigarettes has overshadowed the fact that it is inhaling smoke from burning tobacco, not nicotine, that causes most smoking-related cancers.
Electronic vapour products (EVPs) were developed as a tobacco harm reduction tool and offer an alternative way to consume nicotine without the smoke produced through the burning of tobacco.
Hype and ignorance about EVPs persists, however, even among those involved in public health legislation. This is despite increasing international research in support of EVPs.
A letter from the U.S. office of the attorney general in the Iowa department of justice to the U.S. Food and Drug Administration’s (FDA) director of the Center for Tobacco Products in March 2020 addressed an erroneous FDA statement suggesting that smoking and vaping posed an equal risk to users during the Covid-19 pandemic. It said: “If the FDA is able to provide candid and clear advice that puts the health of millions of Americans first, and this is based on sound behavioural and biomedical insights, then it should do so. If, however, its communications are arbitrary and ill-conceived, spreading fear and confusions with little scientific basis and with unpredictable consequences, then it would be better if the FDA and its media spokespeople did not comment further at this time.”
The letter challenging the FDA was signed by the attorney general and 12 academics and researchers in public health from across the US, Canada and the European Union. Many have acted as consultants to governments during the drafting of legislation around non-combustible nicotine delivery systems. Among them are a number from institutions in the United Kingdom, a global leader in harm reduction policy, and where innovation in the vaping sector has flourished.
The UK now stands as the gold standard for how it regulates, manufactures and sells EVPs. Organisations such as the United Kingdom Vaping Industry Association (UKVIA) are also gaining attention for its position on the critical role that regulation has to play in finding a solution that enshrines both public safety and private entrepreneurship.
South Africa would be wise to follow suit if we are seeking sensible resolutions to the debate around the regulation of EVPs in our own country – and if we are to secure the best possible outcomes in the fight against diseases such as lung cancer and emphysema.
The first steps entail raising the level of understanding among politicians and lawmakers that combustible tobacco products and EVPs are not the same. They should not even share the same legislative platform. To insist that they do will remove an option from millions of South African smokers who are seeking harm-reduced alternatives to cigarettes.
Until the Covid-19 lockdown began in South Africa, EVPs were not legislated in terms of either the Tobacco Products Control Act or the Medicines Act.
That all changed when EVPs were subjected to the same unilateral ban as tobacco products under lockdown. Now, the imminent new Control of Tobacco and Electronic Nicotine Delivery Systems Bill looks to do exactly the same thing: classify nicotine-delivery systems and combustible tobacco products identically – from packaging and the same health warnings to restrictions on all possible distribution and public awareness channels, including advertising.
The problem with such a course of action, advises UKVIA director John Dunne, is that when consumers feel their options are constrained, they look for shortcuts and loopholes. The hard lockdown was evidence of exactly that when black market cigarette sales soared.
Dunne believes the regulatory landscape is at a pivotal point now, with two opposing factions in the ring. One is bent on demonising the consumption of nicotine at all costs, while the other aims to promote vaping as a harm-reduced alternative to smoking. Speaking at a recent VPASA webinar on EVP policy and regulation, Dunne was frank in admitting that nothing we do is 100% safe, but warned that reasonable access, advertising and education are all critical in the creation of successful regulation.
South Africa’s goals are not that far from the UK’s own and, according to Dunne, “the ultimate prize would be regulations that would prevent youth access, but also allow us to reach the adult smoker”.
“It’s really difficult with existing regulations to make that connection with smokers to get them across the line to do something different. But a smoker made to feel like they have options in 2020 is really valuable,” he commented.
At the same webinar, medical doctor and president of the Philippines-based anti-smoking advocacy group Quit for Good, Dr Lorenzo Mata, outlined the role his group had played in that country, shifting the narrative from a complete ban on EVPs to pending regulation in its favour – in just six months. Mata noted that Quit for Good, comprising concerned citizens who recognise the profound damage and loss that cigarettes have brought to that country, were pursuing legislation that enabled citizens to make the best choices for their own health.
“It’s for this reason that we have been at the forefront of advocating for vaping – both in terms of educating the public and in making ongoing representations to our government,” he said.
“Collectively, with the support of other groups also concerned with public health, we have helped to shape a stable and favourable regulatory framework for EVPs, where regulators now intend to regulate EVPs, most importantly, in a risk-proportionate manner relative to cigarettes.”
To be at its most effective, legislation must first interrogate the principles of relative risk and proportionate regulation. If we can convince the South African government to ask those same questions and conduct a full review of all the harms and benefits of specific products such as EVPs, it will be possible for policymakers to reach a science-based conclusion that is in the best interests of all South Africans.
Asanda Gcoyi is the CEO of the Vapour Products Association of South Africa (VPASA). The views expressed are those of the author and do not reflect the official policy or position of Vapor Voice. This opinion first appeared in the Mail & Guardian.
November 3, 2020
Rogers: Anti-Science War Being Waged on Vapor

Credit: Science in HD
The coronavirus pandemic has taught us for certain that public health experts should stick to public health. After suffering through months of the COVID-19 lockdowns and surges, Americans are fully aware how politics and misinformation can negatively impact public health.
The fact is that when the medical and health communities lose their focus on data and science – distracted by partisan advocates and social justice campaigns – Americans pay the ultimate price in terms of their health and well-being.
Just in the last several months, the American public has been bombarded with conflicting reports over the effectiveness of wearing masks to combat COVID-19; whether Hydroxychloroquine is a safe therapy for coronavirus; and the safety of a COVID-19 vaccine. Health and science have been politicized and weaponized for political purposes.
Outside of coronavirus, we have witnessed other “campaigns” that put ideology over science: the anti-vaxxer movement, the anti-GMO movement, and the ongoing disinformation over e-cigarettes.
The Center for Medicine in the Public Interest’s Robert Goldberg recently wrote: “… for all the harm anti-vaccination fabrications have had on public health, a more recent campaign of medical disinformation about the dangers of e-cigarettes is likely to be more damaging by far.”
The U.S. Centers for Disease Control and Prevention (CDC) notes “nearly half a million Americans die prematurely of smoking or exposure to secondhand smoke. (That is about one of every 5 deaths.) Another 16 million live with a serious illness caused by smoking. Smoking-related illness in the United States costs more than $300 billion each year in health care spending and lost productivity.”
E-cigarettes, while not a cure for nicotine dependence, can help reduce the death and disease caused by combustible tobacco. Public Health England (PHE), the United States equivalent of the CDC, concluded best estimates show e-cigarettes are 95% less harmful to your health than normal cigarettes, and when supported by a smoking cessation service, help most smokers to quit tobacco altogether.”
When politics takes precedence over science, we are left with both bad policy and bad science. How does Senator Dick Durbin, D-IL, erroneously declaring on the floor of the United States Senate that “vaping doesn’t guarantee any end to tobacco addiction” help the millions of Americans desperately trying to quit tobacco? What’s more, how does the Democratic leader in the Senate, Chuck Schumer, D-NY, calling vaping devices “ticking time bombs” offer clarity and confidence to smokers looking for alternatives that will help them quit the habit? Senator Schumer actually went so far as to demand that the U.S. Consumer Product Safety Commission take an active role in a “war on vaping.” These assertions betray an anti-corporate ideology (companies that manufacture e-cigs are greedy, evil), not a pro-science stance.
Almost 40 million Americans are addicted to smoking cigarettes. According to the CDC, smoking tobacco is the “leading cause of preventable disease, disability, and death in the United States’ resulting in 480,000 deaths annually in the United States” – which breaks down to 1,300 smoking-related deaths per day, 54 deaths per hour, or almost one death per minute. One dead American every minute and we are playing politics with adult vaping. It is irrational and anti-science.
Are e-cigarettes healthy? Should young people who do not smoke pick up a vaping habit? No, of course not. But these are the wrong questions and not the issue up for public discussion. Rather, the more relevant questions are: “Is vaping a safer alternative to smoking?” “Does vaping help smokers quit tobacco?” And here the answer to both questions is the same: an unequivocal, loud “yes.”
Politicians and ideologically-driven advocates should not be explicitly working to scare tobacco users from using a product that, relative to smoking, does less harm to their health, and is proven to be an effective means in helping them quit smoking altogether.
In 1983, U.S Senator Daniel Patrick Moynihan, declared to his opponents in a policy debate that “you are entitled to your own views, but you are not entitled to your own facts.” What was true in 1983 is still true in 2020. The facts are clear. Vaping bans and politicized attacks on vaping devices hurt those who want to kick the smoking habit.
Here are the facts. Millions of Americans are dying from cigarette smoking because quitting tobacco is extraordinarily difficult. Research, published last year in the New England Journal of Medicine, offers powerful evidence that vaping can help smokers quit cigarettes. Anti-smoking activists and government regulators promoting vaping bans and, in Senator Schumer’s words, fighting a ‘war on vaping’ are not advancing science or good public-health policy. On the contrary, these advocates and politicians are fighting technologies and products that could save millions of American lives.
Let’s stop the war on vaping; let’s take the politics out of health.
This column initially appeared at realclearhealth.com.Jerry Rogers is the editor of RealClearHealth and the host of the ‘Jerry Rogers Show’ on WBAL NewsRadio.
October 28, 2020
GTNF: Future of Nicotine Industry is Less-Risky Products

With clearer information, more smokers would switch to lower-risk products.
By VV Staff
There are several reasons why people use nicotine. According to Neal Benowitz, professor of medicine, biopharmaceutical sciences, psychiatry and clinical pharmacy at the University of California San Francisco, those reasons include pleasure, stimulation and mood modulation. However, many users don’t understand the adverse effects and risks associated with different delivery mechanisms.
“Clearly, the decision involving long-term use of the drug for individuals or society depends, at least in part, on adverse health effects. For example, the casual use of cocaine or heroin are discouraged by society because they are hazardous to health,” explains Benowitz. “We know nicotine, per se, is much less hazardous than cigarette smoking, regardless of potential health concerns. That’s a successful argument for electronic nicotine-delivery systems [ENDS].”
Speaking at a panel titled, “The Future of Nicotine,” during the 2020 Global Tobacco & Nicotine Forum (GTNF) in September, Benowitz said that one of the major questions surrounding tobacco control is whether society can accept nicotine use if the harms were reduced. He says that possibility exists. “The FDA [U.S. Food and Drug Administration] can be a big part of making this happen … there is a misconception surrounding the harm of nicotine compared to combustible products,” which are more deadly than ENDS.
While acknowledging the validity of Benowitz’ point, Michael Cummings, professor of psychiatry and behavioral sciences at the Medical University of South Carolina, cautioned against the unintended consequences of regulation. Banning a specific delivery mechanism for nicotine, he said, presents a risk. Cummings referred to the FDA’s vision, formulated in 2017, of a world where cigarettes would no longer create and sustain addiction and where adults who need or want nicotine could get it from less-harmful alternative sources.
“But it seems like we’re going the wrong direction … If we adopt regulations to ban the sale of vaping products as some states and many countries around the world have done, what would be the effect? Well, the effect is that cigarette sales will go up,” said Cummings. “That’s a bad thing. Regulating vaping products like they’re cigarettes—which they’re not—banning flavors, banning internet sales … [these actions] would have a detrimental effect of actually driving up cigarette sales to the detriment of the lower-risk products.”
Also speaking during the GTNF panel, Clifford E. Douglas, director of the Tobacco Research Network and an adjunct professor of Health Management and Policy at the University of Michigan School of Public Health, said that consumers clearly need a much better understanding of the true nature, including the relative risk, of different tobacco and nicotine products.
“This includes the fact that nicotine is the root cause of the epidemic of tobacco-related illness and death because it hooks in smokers and keeps many smoking who otherwise would quit,” he explained. “While complete information on all the potential risks and benefits of [vapor products] is not yet available, there is sufficient information … to end deadly combustible tobacco use [which is] responsible for approximately half a million deaths a year and 30 percent of all cancer deaths in the United States.”
Asked by moderator Clive Bates, director of Counterfactual Consulting, whether there was a regulatory environment possible that incorporated the relative risk of the different types of nicotine-delivery systems, Stefanie Miller, managing director of FiscalNote Markets, said “no.”
“[There is] no trust among the general public for companies that produce a product containing nicotine, and that is largely based on a misconception around the difference between nicotine and combustible tobacco use. After predatory behavior and negligence of tobacco companies in the 20th Century, most people see this as very black and white. Tobacco companies are bad, and anti-tobacco efforts are purely good,” said Miller. “I think [everyone] who’s tuned in right now knows that the situation is far more nuanced and … the regulations are not accommodative of that nuance.”
Benowitz says that another major problem with the message on less-risky nicotine products is that there is very little science on the long-term effects of ENDS products. “We have an array of new products, any of which are inhalable,” he said. “We have a lot of short-term data that is promising in terms of reduced exposure in the short term, but we really don’t know about the future long-term consequences.”
Miller added that cigarette manufacturers could help change the misconceptions surrounding nicotine. It’s the large manufacturers who could make it a goal to end combustible nicotine-delivery systems. “If you’re really clear about setting a strategic goal, and then you do everything possible to accomplish it, you’re more likely than not to win,” she said. “I think that this is [an] important enough [goal] to try.”
Benowitz said that regulators need to help consumers better understand that the regulators support a shift to less-risky products. He says that only then can the goal of getting rid of combustible products be accomplished.
“We’re not doing this because nicotine is bad,” he said. “We’re doing this because nicotine sustains harmful cigarette smoking … there are other products that [can deliver] nicotine that are much less harmful.”
October 12, 2020
Kazakou: No E-Cig Plain Packaging in Netherlands

Credit: Michal Soukup
The Property Rights Alliance submitted comments to express its significant concerns about the Dutch Executive Order– a proposed bill that would introduce plain packaging (PP) for vaping products and e-cigarettes from 1 January 2022. This measure will create an inhospitable environment for intellectual property rights. Intellectual property rights are human property rights covering dynamic assets and should never be weakened or diluted to meet other political objectives.
In the International Property Rights Index, which is the world’s only index entirely dedicated to the measurement of intellectual and physical property rights, Netherlands ranked 10th out of 129 countries, with a score of 8.273. Regulations such as plain packaging that reduce the ability of owners to use their trademarks erodes such a positive ranking. The scores on the IPRI have robust correlations with Global Biotech Innovation (.92), Global Entrepreneurship (.90), and with Institutional Quality (.91). Indicating that countries with weak protections fail in other areas, the strongest correlation with the IPRI is with the Corruption Perception Index (.93), and specifically with Illicit trade (.89).
Plain packaging, which removes branding (trademarks, colors, corporate logos) has failed to reduce smoking prevalence everywhere it has been tried. In France, where plain packaging has been in force for over three years (implemented on January 1, 2017), published data confirms the policy’s dismal record. The French Customs Office (L’adminstration des Douanes) reported in the course of 2017, a 4% increase in the number of cigarettes purchased compared to the same period of the previous year. The European Tobacco Harm Reduction Advocates (ETHRA) had expressed their concern that measures like standardized packaging will make vaping more expensive, which will prevent adults from turning to these safer solutions and thus prolong the duration of smoking”.
According to the Public Health England (the English Government Public Health agency) and the Tobacco Advisory Committee of the UK Royal College of Physicians, vaping is at least 95 per cent less harmful than smoking. They have emerged as the most popular, and successful, quitting method in countries where it is available, such as in the UK, US, EU and Canada. One of the main findings of the Public Health England (PHE) evidence review is that e-cigarettes could be contributing to at least 20,000 successful new quits per year.
Trademark is a tool for innovators to prevent consumers from being confused by materially different products. Intellectual property fosters economic growth and creates millions of jobs by giving people the incentive to be creative and innovative. In Europe, according to the EU Intellectual Property Office, trademark sectors employ the most of all IP-intensive sectors, namely 30 percent of the workforce directly and indirectly. Protecting intellectual property for vaping products allows innovators to respond to consumer demands for reduced-harm products that had revolutionized the tobacco market. These innovations literally save lives and move science forward. Government regulators that apply plain packaging to vaping products, as they do to tobacco products, reinforce the inaccurate message that they just as harmful or more so.
Tobacco and vaping products are the most illicitly trafficked products in the world. Plain packaging has shown that it not only fails at decreasing smoking rates, but that it may also be connected to increases in illicit sales of tobacco. After Australia adopted plain packaging, illicit tobacco consumption increased by 14 percent. Removing trademarks on packaging allows illicit markets, including counterfeiting, easier access to unwilling consumers and retailers. Plain packaging would lead to a dramatic rise in the illegal e-cigarette market where plain-packaged cigarettes can be copied much more quickly than the branded packs.
IP rights like trademarks and brands should be protected for consumer welfare. Governments should introduce modest regulations for e-cigarettes and product safety approaches. The introduction of the proposed legislation constitutes a breach of the IP rights and right of expression of the manufacturers. The freedom of speech supports the freedom of industry to articulate its ideas without fear of retaliation or legal sanction, such plain packaging.
This opinion was written by Chrysa K. Kazakou for The Property Rights Alliance.
October 6, 2020